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Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX

A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...

Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO

Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO

Clinical Regional Monitoring - 15 Years of Experience - Near 75219

Professional Summary Accomplished and energetic Senior Clinical Research Associate with a solid history of achievement in monitoring clinical trials. Motivated leader with strong organizational and prioritization abilities. Performed lead study duties to include trip report review and expense reporting. Mentored junior level CRAs and provided feedback and constructive critiques. Interested in senior positions as a research ...

Ideal Companies: Allergan, Bayer, CMED, Novartis, Pfizer, Paidion Research,

Tags for this Online Resume: Clinical Research, Research, Medical, Medical Records, Monitoring, Documentation, Protocol, Complaints, Nursing, Ophthalmology

Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

Clinical Research Project Manager Interested in Growing with a Patient Centered Organization

​My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...

Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.

Dedicated healthcare professional

Dedicated healthcare professional with 14 years of clinical, administrative and management experience, including 6 years as a Clinical Research Coordinator and 14 years as a Medical Assistant. Combined clinical skills and business acumen. Excellent communication and interpersonal skills. Master of Science in Clinical Research Administration degree.

Ideal Companies: Clinical Research

Tags for this Online Resume: Recruiting, Microsoft office, Liaison, Employee Development, Clinical Research Coordinator, Medical Records, Healthcare Administration, Management, Data Collection, Analysis, Medical Terminology

Vice President - 20 Years of Experience - Near 08055

International agricultural product business development for 5 different types of job fields: (a) Biopesticides, (b) Agricultural Chemicals, (c) Innovation Technologies, (d) Produce Companies and (e) Nonprofit Global Research Organization.

Ideal Companies: International Agricultural Product Business Development, USA Agricultural Product Business Development

Tags for this Online Resume: Sales, Regulatory Affairs, Product Development, Management, Business Development, Development Initiatives, Light Emitting Diode, Quality, Quality Assurance, Global Agricultural Chemicals & Biopesticides Expert, Research & Development, International Regulatory Affairs, Project Management, Sustainable Agriculture, multilingual/multicultural skills, consistently successful diversified professional profile leading multinational corporations as well as innovation technologies’ start-ups, Motivational and inspirational leader

I am a Regisered Nurse with interests and experience in Clinical Regional Monitoring and Clinical Management/Project Manager - 15 Years of Experience - Near 06512

I have a strong clinical background as a Registered Nurse prior to my joining the pharmaceutical industry. This has been beneficial in the course of my career. I have expertise in many areas and observational abilities in tracking subject safety and tolerability. I am aware of site challenges, having conducted clinical trials in large hospital settings as an RN and can be supportive and provide suggestions to sites when ch...

Ideal Companies: DOCs ICON Pfizer

Tags for this Online Resume: Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review